SARS-CoV-2 immunochromatographic IgM/IgG rapid test in pregnancy: A false friend?. (March 2021)

• Record Type: Journal Article
• Authors: Fabre, M; Ruiz-Martinez, S; Monserrat Cantera, ME; Cortizo Garrido, A; Beunza Fabra, Z; Peran, M; Benito, R; Mateo, P; Paules, C; Oros, D
• Is Part Of: Annals of clinical biochemistry. Volume 58:Number 2(2021)
• Page Start: 149
• Page End: 152
• Publication Date: 2021-03
• Subjects: Clinical studies -- immunoassay -- laboratory methods -- pregnancy; Clinical chemistry -- Periodicals; Clinical biochemistry -- Periodicals; 616.075
• DOI: 10.1177/0004563220980495
• Languages: English
• ISSNs: 0004-5632

Abstract

Background: An increasing body of evidence has revealed that SARS-CoV-2 infection in pregnant women could increase the risk of adverse maternal and fetal outcomes. Careful monitoring of pregnancies with COVID-19 and measures to prevent neonatal infection are warranted. Therefore, rapid antibody tests have been suggested as an efficient screening tool during pregnancy. Cases: We analysed the clinical performance during pregnancy of a rapid, lateral-flow immunochromatographic assay for qualitative detection of SARS-CoV-2 IgG/IgM antibodies. We performed a universal screening including 169 patients during their last trimester of pregnancy. We present a series of 14 patients with positive SARS-CoV-2 immunochromatographic assay rapid test result. Immunochromatographic assay results were always confirmed by chemiluminescent microparticle immunoassays for quantitative detection of SARS-CoV-2 IgG and IgM+IgA antibodies as the gold standard. We observed a positive predictive value of 50% and a false positive rate of 50% in pregnant women, involving a significantly lower diagnostic performance than reported in non-pregnant patients. Discussion: Our data suggest that although immunochromatographic assay rapid tests may be a fast and profitable screening tool for SARS-CoV-2 infection, they may have a high false positive rate and low positive predictive value in pregnant women. Therefore, immunochromatographic assay for qualitative detection of SARS-CoV-2 IgG/IgM antibodies must be verified by other test in pregnant patients.